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Timing On User Fee Votes Up In Air, As GOP Delays Senate Health Care Bill Battle

Senate leaders had shoved a floor vote on the five-year device and drug user fee reauthorization bill to the back burner to make room for a pre-July 4 vote on the Senate's Obamacare repeal bill, the Better Care Reconciliation Act. But Senate Majority Leader Mitch McConnell is now delaying a vote to get more votes, a step that could further throw off the timing of FDARA passage.

Legislation Policy United States

US FDA Faces Down Complex Combo Products, Fires Up Oncology Center Of Excellence

FDA officials discuss difficulties dealing with complex combination products, the future of the agency's product centers, and promotion of industry collaboration at the Drug Information Association's annual meeting.

Combination Products Regulation FDA

Medtronic Enters New Outcomes-Based Insulin Pump Deal With Aetna

The device-maker will be on the hook to provide rebates to the health insurer if it's self-adjusting insulin pumps don't maintain patients in appropriate glucose ranges under a newly inked agreement. Medtronic already has a similar arrangement with UnitedHealthCare.

Market Access Reimbursement Commercial

Virtual Reality: The New Game In Mental Health Care To Improve Outcomes

Virtual reality is seeing an upsurge in use by mental health practitioners for treating conditions such as post-traumatic stress disorder, panic disorders and anxiety in a safe and controlled manner. With the advent of affordable VR headsets and technological advances, companies and researchers worldwide are seizing on the opportunity to bring such techniques as VR exposure therapy and cognitive behavioral therapy to telemedicine, specialty clinics and directly to consumers to improve outcomes and better lives.

Neurology Innovation Market Intelligence

Recent Tweets from Medtech Insight

Policy & Regulation Explore this Topic

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Q&A: FDA Dx Reviewer's Tips For Next-Gen Sequencing Sponsors

A top reviewer in US FDA's in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common submission shortcomings in this interview with Medtech Insight. According to FDA's Hisani Madison, sponsors frequently fall short in providing a refined intended-use statement.

In Vitro Diagnostics Personalized Medicine Regulation

Compliance Corner: Keep 'ALCOA' In Mind To Ensure Quality Data Integrity, Says US FDA Expert

When inspecting a device manufacturing facility, FDA investigators will check a company's quality data to make sure it's Attributable, Legible, Contemporaneous, Original and Accurate – or "ALCOA," the agency's national device expert says.

Quality Control Compliance Medical Device

Draft Drug Executive Order Could Impact Device Regulations

Over the past week a draft executive order has been floating around that aims to deregulate the bio-pharmaceutical industry while also reducing costs for medical products. While aimed at drugs, the order seems to encompass all medical products.

Regulation Pricing Debate

Acting US FDA Chief Scientist Tapped, As Borio Moves To White House Biodefense Detail

FDA promotes Denise Hinton to acting chief scientist after Luciana Borio is detailed to the National Security Council for biodefense work

FDA Policy

Warning Letter Roundup & Recap – June 27, 2017

US FDA did not release any device-related warning letters the week of June 27.

Device Warning Letters Medical Device

Lawmakers Prod Trump To Talk Trade Barriers, Stent Price Caps With India's Modi

US President Trump met with India Prime Minister Modi June 26 in Washington, DC. Trade barriers were one topic on the agenda, and lawmakers in Congress has suggested recent price caps placed on coronary stents in India as one specific issue that should get attention from the leaders.

Policy Trade

EU's MDR: When Three Plus Four Does Not Necessarily Make Seven

Companies hoping to keep their medtech products certified under the current Medical Devices Directive on the market until May 2024 need a reality check, experts say. Things may not be as they seem.

Medical Device Europe

CMS Proposes High Payment Score For Use Of Imaging Appropriate-Use Criteria

In a proposed rule, the US Medicare agency said clinicians may count use of advanced imaging appropriate use criteria (AUC) through clinical decision support as a new and highly-weighted portion of an overall score to win reimbursement through the Merit-Based Incentive Payment System. The move was touted by the imaging industry.

Reimbursement Regulation

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Zimmer: Surprised By Biomet Quality Problems, But Responded Before FDA Arrived

Zimmer Biomet's response to a US FDA Form-483 says the firm was unaware of the quality systems woes at the targeted Biomet Warsaw, Ind., plant before its 2015 acquisition of the company. But, it emphasized, comprehensive fixes were in the works even before the 2016 agency inspection that generated more than a dozen substantive observations took place.

Quality Control Compliance

Compliance Corner: US FDA Wants Device Firms To Fully Consider Risks To Consumers, Agency Expert Says

Manufacturers that don't consider all possible dangers their products can pose to consumers is a growing problem, FDA's national expert on devices says. Phil Pontikos also is worried that firms aren't putting their best foot forward when using risk assessment tools.

Risk Management Compliance

As Device Firms Take Costa Rica By Storm, Quality Control Experts Champion 'Pura Vida'

"Pura Vida" – a Spanish phrase meaning the "pure" or "simple life" – isn't just the unofficial motto of Costa Rica; rather, it's a state of mind, locals say. But as more and more medical device manufacturing facilities pop up in the tiny Central American nation, quality assurance professionals there have discovered that ensuring top-notch product quality doesn't necessarily make life simpler. To jump that hurdle, QA experts from a variety of firms – including Medtronic, Precision Concepts and Creganna Medical – have banded together to lean on each other as they search for solutions to quality systems issues, as well as knowledgeable input on hot quality and compliance topics.

Quality Control Compliance

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Calcivis Ready To Sink Teeth Into UK Market With Imaging Device

Scottish dental technology specialist Calcivis is gearing up for a UK launch of its tooth imaging device. The Edinburgh-based company has developed the Caries Activity Imaging System which can detect calcium deficiencies in tooth enamel that could signal the onset of cavities and thus inform preventive treatment decisions.

Dental Oral StartUps and SMEs Innovation

Latest From Commercial

Sophia Genetics' AI Brings In More Standardization To Liquid Biopsies

Swiss specialist in data-driven medicine Sophia Genetics has developed a new AI clinical application for clinicians to analyze liquid biopsy results. The technology utilizes the company's artificial intelligence platform SOPHiA

Digital Health Cancer

RepliCel Poised To Partner Up For Precision-Control Dermal Injector

RepliCel Life Sciences is set to unveil in July the first functioning prototype of its next-generation dermal injector, which the company said has already sparked the interest of big dermal filler manufacturers. While the technology had been developed originally to deliver RepliCel's cell therapies for pattern baldness and aging or sun-damaged skin, the company believes the injector's unique features – including electronically-controlled dosing and delivery – allow it to be used in myriad applications.

Dermatology Regenerative Medicine

Philips Completes M&A Hat Trick With Neurodiagnostic Buy

In its third acquisition this year so far, Philips is buying neurodiagnostic firm Electrical Geodesics.

Neurology Diagnostics

Bonesupport Cements Funding With SEK 500m IPO

Swedish orthobiologics company Bonesupport has closed its initial public offering on the Nasdaq Stockholm exchange, raising SEK500m ($57m) from retail and institutional investors.

Orthopedics Financing

UK Medtech Upscales International Plans Ahead of Brexit

As the UK prepared to leave the EU, the local medtech industry, represented by the Association of British Healthcare Industries, has been busy finding ways to make up for any potential restrictions on market access and business development. On June 21, it announced a three-year growth plan, as explained by ABHI managing director of international Paul Benton in this Medtech Insight podcast interview.

United Kingdom Brexit

Stryker Doubles Down On Novadaq To Boost Medsurg

Stryker is set to expand its surgical offerings after signing a $701m deal to buy Novadaq Technologies, a leading developer of fluorescence surgical imaging technology. The acquisition price is a 96% premium over Novadaq's June 16 closing price, which, according to analysts, is believed to be due to a competitive bidding process for the company.

M & A Surgery

Clinical R&D Explore this Topic

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Starts & Stops: Corlife's Decellularized Human Pulmonary Valve Shows Early Promise

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. News about trials of cardiovascular devices, especially novel heart valve replacement technologies, lead this month's edition, covering mid-May through mid-June.

Starts & Stops Clinical Trials Research & Development

Latest From Research & Development

Positive Data Give DePuy Synthes' Attune Further Knee-Up

Results of a study by the Canadian Radiostereometric Analysis Network show that the tibial base of DePuy Synthes' Attune knee replacement achieves stable fixation out to two years and recently announced results from the UK's National Joint Registry show a 98.1% four-year implant survivorship rate with Attune in a "real-world" setting.

Orthopedics Clinical Trials

Device Week – June 16, 2017

On this week's Medtech Insight podcast: expect digital health guidance documents from US FDA soon, the agency’s commissioner says; FDA optimistic it will push out a final version of a 3D printing manufacturing guidance this year; US government releases data on the number of people who would lose health insurance under the American Health Care Act; Wells Fargo report fingers which device types would be most impacted by Trumpcare; a look at FDA approval and clearance trends, including a noticeable increase in 510(k)s; new clinical data releases discussed.

FDA Digital Health

INS 2017: Neuromodulation's Future Features Innovative Power Source, Materials And Treatment Protocols

Neuromodulation technology is advancing at breakneck speed, as physicians, academic, and industry innovators deepen their understanding of the field and learn what works and what doesn't. At the Innovations Day held during the 13th world congress of the International Neuromodulation Society in Edinburgh, Scotland, Medtech Insight highlights the notable new techs that are in the pipeline of emerging companies.

Neurology Innovation

OUS Approvals Analysis: IVDs Lead A Slow Month

Only 10 approvals from outside the US were recorded in May in Medtech Insight's approvals tracker. Half of those were for in vitro diagnostics, including three for companion diagnostic for cancer drugs.

Approvals Innovation

Start-Up Spotlight: LensGen, Eye On The Presbyopia Prize

Restoring the eyes' ability to accommodate and seamlessly focus on near and far objects continues to be the holy grail in ophthalmology. Accommodating intraocular lenses offer one approach to tackle presbyopia and allow patients the possibility of eschewing reading glasses. LensGen is one company going down that road and it successfully raised $21m in series A financing – with major optical lens maker Hoya among its backers – in April to advance its fluid-based accommodating IOL, Juvene.

Ophthalmology Innovation

ASCO 2017: Myriad's MyRisk; Nanobiotix' NBTXR3; Chronix' CNI Test; Sirtex SIR-Spheres; ANGLE’s Parsortix CTC Harvester

Over 30,000 oncologists and other health professionals attended the 2017 American Society of Clinical Oncology annual meeting in Chicago, June 2-6. This year's meeting included several presentations on emerging cancer diagnostic and device treatment strategies, including genetic tests, liquid biopsy systems, radioenhancers, and microspheres intended to improve chemotherapy outcomes.

Cancer In Vitro Diagnostics